The World Health Organization on Friday approved an emergency COVID-19 vaccine from the Chinese state-run drugmaker Sinopharm, reinforcing Beijing’s desire to play an important role in vaccinating the world.
The vaccine, one of two major Chinese coronavirus vaccines given to hundreds of millions of people in China and elsewhere, is the first to be developed by a non-Western country and recognized by the WHO.
It is also the first time WHO approves the emergency use of a Chinese vaccine. Earlier this week, several WHO experts had raised concerns about the quality of the data the company had provided on side effects.
A WHO emergency listing is a signal to national regulatory authorities that a product is safe and effective. It also allows it to be included in COVAX, a global program to deliver vaccines primarily to poor countries that has impacted supply issues.
“This expands the list of COVID-19 vaccines that COVAX can purchase and gives countries the confidence to expedite their own regulatory approval and import and deliver a vaccine,” WHO Director General Tedros Adhanom Ghebreyesus said in a meeting.
Senior WHO adviser Bruce Aylward said it is up to Sinopharm to say how many doses of its vaccine it can provide for the program, but added, “They are trying to provide substantial support, make substantial doses available while, of course, trying to serve the Chinese people.”
The WHO had already given emergency approval to COVID-19 vaccines developed by Pfizer-BioNTech, AstraZeneca, Johnson & Johnson and, last week, Moderna.
The decision to approve the Sinopharms vaccine was made by the WHO’s technical advisory group, which began meeting on April 26 to review the latest clinical data and manufacturing practices for Sinopharms.
“Because of its easy storage requirements, it is very suitable for low-resource settings,” a WHO statement said.”
Tedros said that once approved, his separate Strategic Advisory Group of Experts recommended adults over 18 to receive two doses of the Sinopharm vaccine.
“Based on all available evidence, WHO recommends the vaccine for adults aged 18 years and older, in a two-dose schedule with an interval of three to four weeks,” the WHO statement said.
The vaccine, developed by the Beijing Institute of Biological Products, a unit of Sinopharm subsidiary China National Biotec Group, has an estimated 79% effectiveness for all age groups, it said.
However, he added, “Few older adults have entered clinical trials, so efficacy in this age group could not be estimated.”
The WHO has announced that it will make a decision on China’s other main COVID-19 vaccine from Sinovac Biotech next week. Technical experts checked it on Wednesday. Didier Laurent, chairman of the WHO technical advisory group, said at the press conference: We have started to review the Sinovac report. In fact, we have requested additional information from the manufacturer … which we will hopefully receive very soon to make a decision.”
China has deployed around 65 million doses of Sinopharm vaccine and more than 200 million doses of Sinovac vaccine. Both have been exported to many countries, particularly Latin America, Asia and Africa, many of which have had difficulty obtaining the vaccines developed in the West.
